(The trial has been terminated earlier following the company decision to discontinue the clinical development of Evofosfamide)

Sponsor:

EMD Serono

ClinicalTrials.gov Identifier:

NCT02047500

First Posted: January 28, 2014

Last Update Posted: June 10, 2016

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An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Number of subjects experiencing dose limiting toxicity (DLT) [ Time Frame: Up to Day 28 of Cycle 1 ]

Secondary Outcome Measures:

Progression free survival (PFS) time [ Time Frame: Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment ]

Percentage of subjects with objective response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) criteria [ Time Frame: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment ]

Duration of overall response according to RECIST version 1.1 criteria [ Time Frame: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment ]

Percentage of subjects with disease control according to RECIST version 1.1 criteria [ Time Frame: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment ]

Tumor metabolic response assessed by positron emission tomography (PET) scans according to European Organization for Research and Treatment of Cancer (EORTC) criteria [ Time Frame: Baseline and 8 weeks after Day 1 of Cycle 1 ]

Number of subjects with Treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline up to Day 30 after the last dose of study treatment ]

TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Drug: Nab-paclitaxel

Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Drug: Gemcitabine

Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects greater than or equal to (>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:

Radiosensitizing doses of 5-fluorouracil;

Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;